A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients

Trial Profile

A Phase 1, Open-label, Multi-center, Dose-escalation Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of ISU304 in Previously Treated Hemophilia B Patients

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 18 Dec 2017

At a glance

  • Drugs CB 2679d (Primary) ; CB 2679d (Primary) ; Nonacog alfa (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; First in man; Proof of concept
  • Sponsors ISU Abxis
  • Most Recent Events

    • 18 Dec 2017 According to a Catalyst Biosciences media release, the Korean Ministry of Food and Drug Safety (MFDS) has approved a protocol amendment to omit single dose Cohort 4 (300 IU/kg daily "high dose") and move directly to multi-dose Cohort 5 at 150 IU/kg daily in this trial.
    • 12 Dec 2017 Interim results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
    • 09 Dec 2017 Interim results from three cohorts presented in a Catalyst Biosciences media release.
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